NIH VideoCast - Investigational New Drug (IND) Applications: What You Need to Know for Successful Interactions with the FDA

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Investigational New Drug (IND) Applications: What You Need to Know for Successful Interactions with the FDA

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Air date:	Thursday, December 12, 2013, 8:00:00 AM Time displayed is Eastern Time, Washington DC Local
Views:	Total views: 651 (100 Live, 551 On-demand)
Category:	Conferences
Runtime:	05:38:02
Closed captioning:	Check box to display CC outside of the video Note: You can drag the captioning window around and resize it
Description:	An educational program of the NIH Clinical Center-FDA CDER Joint Task Force emphasizing regulatory requirements for clinical trials of new and repurposed drugs, with a special focus on rare diseases. Target Audience: Clinical investigators, clinical research study coordinators, clinical and translational research scientists and trainees. Objectives: • To provide training in FDA regulations for NIH investigators involved in phase I and phase II clinical trials of investigational drugs, emphasizing safety considerations in the early phases of drug development. • To describe the IND-enabling elements of non-clinical research that are required to implement a first-in-human clinical trial, including chemistry, manufacturing, and controls (CMC) conducted under good manufacturing practice (GMP) conditions, and non-clinical pharmacology and toxicology studies. • To address special considerations applicable to drug development for rare diseases, including limited number of patients and the need for well-designed, efficient, and informative phase I-II clinical trials to support further development of novel therapies for rare diseases. • To inform the NIH clinical research community about new web-based tools that will facilitate IND submissions.

Author:	NIH Clinical Center

CIT Live ID:	13329
Permanent link:	https://videocast.nih.gov/watch=13329